A Phase 3 interventional study of Eluxadoline and Placebo in Irritable Bowel Syndrome, sponsored by Furiex Pharmaceuticals, Inc. Completed at 283 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-09-04.
Sponsored by Furiex Pharmaceuticals, Inc · Phase 3, Interventional, and Treatment
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 1,282 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Furiex Pharmaceuticals, Inc is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participant has had a colonoscopy performed:
Since the onset (if applicable) of any of the following alarm features for participants of any age:
Female participants must be:
Exclusion Criteria:
Participant has any of the following surgical history:
Other protocol-specific eligibility criteria may apply.
Eluxadoline 75 mg tablets, orally, twice daily for up to 52 weeks period.
Drug: Eluxadoline
Eluxadoline 100 mg tablets, orally, twice daily for up to 52 weeks period.
Drug: Eluxadoline
Eluxadoline placebo matching tablets, orally, twice daily for up to 52 weeks period.
Drug: Placebo
Oral tablets twice daily
Also known as: JNJ-27018966
Oral tablets twice daily
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores
Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score \<5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
Time frame: Up to 12 Weeks
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores
Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score \<5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
Time frame: Up to 26 Weeks
Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals
Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by ≥30% compared to baseline) for at least 50% of days with diary entries during each interval. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.
Time frame: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals
Stool consistency responders: participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval. BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder.
Time frame: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals
IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 \[none\] or 1 \[mild\]; or a daily IBS-d global symptom score improved by ≥2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval. IBS-d Global Symptom Scale was a 5 point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.
Time frame: 12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)
Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale
IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit. The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation.
Time frame: Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (End of Treatment [EOT])
Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale
Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary. IBS-AR responders were defined as participants with a weekly response of "Yes" to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval. A participant must have had a positive response on ≥6 weeks for the 12-week interval and ≥13 weeks for the 26-week interval, regardless of diary compliance, to be a responder.
Time frame: 12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)
Change From Baseline in Daily Abdominal Discomfort Scores
Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort. A negative change from Baseline indicates the discomfort decreased.
Time frame: Baseline, Weeks 4, 12 and 26
Change From Baseline in Daily Abdominal Bloating Scores
Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating. A negative change from Baseline indicates the bloating decreased.
Time frame: Baseline, Weeks 4, 12 and 26
Number of Bowel Movements Per Day
Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.
Time frame: Weeks 4, 12 and 26
Number of Bowel Incontinence Episodes
Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.
Time frame: Weeks 4, 12 and 26
Number of Bowel Incontinence Free Days
An incontinence free day was one where the participant reports zero incontinence episodes. The number of incontinence free days for a participant was assessed each week based on the number of reported days.
Time frame: Weeks 4, 12 and 26
Number of Urgency Episodes Per Day
Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.
Time frame: Weeks 4, 12 and 26
IBS-QoL Total Scores
The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation.
Time frame: Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (EOT)
Change From Baseline in IBS-QoL Total Scores
The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved.
Time frame: Baseline, Weeks 4, 8, 12, 18, 26, 36, 44, and 52/EOT
| Milestone | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Started | 429 | 426 | 427 |
| Attended week 12 visit | 341 | 330 | 342 |
| Attended week 26 visit | 289 | 291 | 290 |
| Completed | 257 | 257 | 269 |
| Not completed | 172 | 169 | 158 |
| Withdrew: Voluntarily withdrew | 94 | 79 | 96 |
| Withdrew: Adverse event | 36 | 45 | 16 |
| Withdrew: Lost to follow-up | 25 | 23 | 16 |
| Withdrew: Physician decision: other | 11 | 14 | 16 |
| Withdrew: Physician decision: lack of efficacy | 2 | 3 | 7 |
| Withdrew: Protocol violation | 3 | 4 | 4 |
| Withdrew: Sponsor decision | 1 | 0 | 3 |
| Withdrew: Randomized and never dispensed drug | 0 | 1 | 0 |
Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score \<5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
| percentage of participants | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores | 23.9 | 25.1 | 17.1 |
Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score \<5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
| percentage of participants | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores | 23.4 | 29.3 | 19.0 |
Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by ≥30% compared to baseline) for at least 50% of days with diary entries during each interval. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.
| percentage of participants | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Responders during Weeks 1-12 | 42.4 | 43.2 | 39.6 |
| Responders during Weeks 1-26 | 45.2 | 46.5 | 43.3 |
| Responders during Weeks 1-4 | 40.5 | 44.4 | 37.5 |
| Responders during Weeks 5-8 | 44.5 | 47.2 | 45.4 |
| Responders during Weeks 9-12 | 44.5 | 45.8 | 43.8 |
| Responders during Weeks 13-16 | 44.3 | 44.1 | 45.4 |
| Responders during Weeks 17-20 | 44.7 | 43.2 | 41.5 |
| Responders during Weeks 21-24 | 44.7 | 42.0 | 38.4 |
Stool consistency responders: participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval. BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder.
| percentage of participants | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Responders during Weeks 1-12 | 30.0 | 34.3 | 22.0 |
| Responders during Weeks 1-26 | 28.1 | 34.0 | 24.1 |
| Responders during Weeks 1-4 | 28.8 | 31.5 | 19.0 |
| Responders during Weeks 5-8 | 31.1 | 35.2 | 24.1 |
| Responders during Weeks 9-12 | 29.0 | 35.2 | 24.6 |
| Responders during Weeks 13-16 | 27.6 | 32.9 | 24.4 |
| Responders during Weeks 17-20 | 31.9 | 31.5 | 23.7 |
| Responders during Weeks 21-24 | 30.2 | 30.3 | 24.4 |
IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 \[none\] or 1 \[mild\]; or a daily IBS-d global symptom score improved by ≥2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval. IBS-d Global Symptom Scale was a 5 point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.
| percentage of participants | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Responders during Weeks 1-12 | 35.1 | 34.7 | 28.8 |
| Responders during Weeks 1-26 | 36.3 | 37.1 | 32.3 |
| Responders during Weeks 1-4 | 32.6 | 31.9 | 26.9 |
| Responders during Weeks 5-8 | 37.0 | 38.7 | 32.8 |
| Responders during Weeks 9-12 | 35.6 | 36.6 | 34.0 |
| Responders during Weeks 13-16 | 35.8 | 35.9 | 35.4 |
| Responders during Weeks 17-20 | 37.5 | 36.4 | 33.3 |
| Responders during Weeks 21-24 | 36.8 | 35.2 | 29.5 |
IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit. The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation.
| percentage of participants | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Responders at Week 4 | 42.6 | 44.1 | 37.0 |
| Responders at Week 8 | 43.8 | 49.8 | 41.7 |
| Responders at Week 12 | 44.3 | 48.1 | 44.0 |
| Responders at Week 18 | 44.5 | 45.1 | 43.3 |
| Responders at Week 26 | 45.4 | 45.1 | 40.0 |
| Responders at Week 36 | 41.0 | 43.2 | 39.6 |
| Responders at Week 44 | 39.6 | 40.1 | 37.5 |
| Responders at Week 52/EOT | 49.4 | 54.9 | 47.8 |
Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary. IBS-AR responders were defined as participants with a weekly response of "Yes" to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval. A participant must have had a positive response on ≥6 weeks for the 12-week interval and ≥13 weeks for the 26-week interval, regardless of diary compliance, to be a responder.
| percentage of participants | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Responders during Weeks 1-12 | 52.9 | 54.2 | 43.8 |
| Responders during Weeks 1-26 | 45.7 | 49.5 | 40.0 |
Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort. A negative change from Baseline indicates the discomfort decreased.
| score on a scale | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Change at Week 4 | -2.24 ± 2.204 | -2.41 ± 2.326 | -2.01 ± 2.156 |
| Change at Week 12 | -2.75 ± 2.534 | -2.97 ± 2.526 | -2.61 ± 2.444 |
| Change at Week 26 | -3.27 ± 2.578 | -3.52 ± 2.543 | -3.00 ± 2.579 |
Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating. A negative change from Baseline indicates the bloating decreased.
| score on a scale | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Change at Week 4 | -1.84 ± 2.303 | -2.03 ± 2.333 | -1.72 ± 2.303 |
| Change at Week 12 | -2.42 ± 2.616 | -2.49 ± 2.533 | -2.16 ± 2.544 |
| Change at Week 26 | -2.76 ± 2.823 | -2.94 ± 2.576 | -2.47 ± 2.562 |
Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.
| bowel movements per day | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Week 4 | 3.20 ± 2.090 | 3.20 ± 2.236 | 3.72 ± 2.100 |
| Week 12 | 3.12 ± 2.143 | 3.09 ± 2.318 | 3.44 ± 1.987 |
| Week 26 | 2.83 ± 2.158 | 2.79 ± 2.270 | 3.12 ± 1.831 |
Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.
| incontinence episodes | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Week 4 | 0.74 ± 1.603 | 0.72 ± 1.534 | 0.93 ± 2.140 |
| Week 12 | 0.63 ± 1.542 | 0.71 ± 1.663 | 0.94 ± 3.612 |
| Week 26 | 0.46 ± 1.298 | 0.58 ± 1.358 | 0.69 ± 1.500 |
An incontinence free day was one where the participant reports zero incontinence episodes. The number of incontinence free days for a participant was assessed each week based on the number of reported days.
| days | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Week 4 | 4.83 ± 2.745 | 4.95 ± 2.618 | 4.63 ± 2.741 |
| Week 12 | 4.96 ± 2.672 | 4.79 ± 2.671 | 4.64 ± 2.704 |
| Week 26 | 4.39 ± 2.465 | 4.35 ± 2.449 | 4.00 ± 2.539 |
Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.
| episodes per day | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Week 4 | 1.75 ± 1.840 | 1.74 ± 1.879 | 2.19 ± 2.082 |
| Week 12 | 1.55 ± 1.777 | 1.60 ± 1.995 | 1.81 ± 1.883 |
| Week 26 | 1.25 ± 1.773 | 1.45 ± 2.113 | 1.55 ± 1.853 |
The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation.
| score on a scale | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Responders at Week 4 | 62.37 ± 23.747 | 64.34 ± 24.049 | 57.13 ± 24.318 |
| Responders at Week 8 | 66.22 ± 23.919 | 67.73 ± 23.421 | 59.46 ± 24.323 |
| Responders at Week 12 | 66.80 ± 24.131 | 68.93 ± 23.938 | 61.72 ± 25.545 |
| Responders at Week 18 | 68.75 ± 23.902 | 70.05 ± 23.662 | 63.60 ± 24.618 |
| Responders at Week 26 | 70.74 ± 23.312 | 71.34 ± 23.106 | 64.83 ± 24.380 |
| Responders at Week 36 | 70.53 ± 23.043 | 72.37 ± 23.246 | 66.47 ± 24.034 |
| Responders at Week 44 | 70.30 ± 24.408 | 72.15 ± 24.398 | 65.59 ± 25.045 |
| Responders at Week 52/EOT | 68.85 ± 24.754 | 71.02 ± 24.294 | 63.93 ± 26.359 |
The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved.
| score on a scale | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Change at Week 4 | 16.49 ± 20.693 | 17.86 ± 20.191 | 13.25 ± 18.475 |
| Change at Week 8 | 19.88 ± 21.855 | 21.08 ± 21.347 | 15.76 ± 19.398 |
| Change at Week 12 | 20.26 ± 23.412 | 22.76 ± 22.592 | 17.76 ± 21.523 |
| Change at Week 18 | 23.09 ± 23.846 | 24.18 ± 23.025 | 19.80 ± 22.368 |
| Change at Week 26 | 25.28 ± 23.679 | 25.80 ± 23.998 | 20.62 ± 22.306 |
| Change at Week 36 | 25.37 ± 24.603 | 27.18 ± 24.201 | 22.64 ± 23.414 |
| Change at Week 44 | 25.13 ± 24.948 | 26.64 ± 25.017 | 21.77 ± 23.977 |
| Change at Week 52/EOT | 23.30 ± 23.959 | 25.86 ± 23.854 | 20.66 ± 23.956 |
Collected over Up to 54 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eluxadoline 75 mg | 0/428 (0%) | 25/428 (5.8%) | 84/428 (19.6%) |
| Eluxadoline 100 mg | 0/479 (0%) | 27/479 (5.6%) | 89/479 (18.6%) |
| Placebo | 0/427 (0%) | 16/427 (3.7%) | 47/427 (11%) |
| Event | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| Abdominal painGastrointestinal disorders | 1/428 | 3/479 | 0/427 |
| DiverticulitisInfections and infestations | 2/428 | 1/479 | 0/427 |
| InfluenzaInfections and infestations | 2/428 | 0/479 | 0/427 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/428 | 0/479 | 1/427 |
| Pancreatitis acuteGastrointestinal disorders | 1/428 | 2/479 | 0/427 |
| Angina pectorisCardiac disorders | 1/428 | 2/479 | 0/427 |
| Road traffic accidentInjury, poisoning and procedural complications | 1/428 | 2/479 | 0/427 |
| AnxietyPsychiatric disorders | 0/428 | 2/479 | 1/427 |
| HemorrhoidsGastrointestinal disorders | 0/428 | 0/479 | 1/427 |
| Irritable bowel syndromeGastrointestinal disorders | 0/428 | 0/479 | 1/427 |
| Event | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo |
|---|---|---|---|
| ConstipationGastrointestinal disorders | 27/428 | 44/479 | 12/427 |
| NauseaGastrointestinal disorders | 34/428 | 31/479 | 19/427 |
| Upper respiratory tract infectionInfections and infestations | 14/428 | 25/479 | 15/427 |
| VomitingGastrointestinal disorders | 22/428 | 19/479 | 7/427 |
Enrolled Set included 1282 participants who were randomized or received at least one dose of study drug.
| Age, Continuous(years) | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 44.5 ± 13.18 | 44.4 ± 13.91 | 45.8 ± 14.10 | 44.9 ± 13.74 |
| Age, Customized(Participants) | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo | Total |
|---|---|---|---|---|
| 18-40 years | 173 | 166 | 159 | 498 |
| 41-64 years | 227 | 225 | 217 | 669 |
| ≥65 years | 29 | 35 | 51 | 115 |
| Sex: Female, Male(Participants) | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 278 | 283 | 277 | 838 |
| Male | 151 | 143 | 150 | 444 |
| Race/Ethnicity, Customized(Participants) | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo | Total |
|---|---|---|---|---|
| White | 374 | 368 | 370 | 1112 |
| Black | 46 | 48 | 46 | 140 |
| Asian | 3 | 3 | 4 | 10 |
| American Indian or Alaska Native | 1 | 2 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Other | 5 | 4 | 6 | 15 |
| Race/Ethnicity, Customized(Participants) | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 119 | 117 | 125 | 361 |
| Not Hispanic or Latino | 310 | 309 | 302 | 921 |
| Body Mass Index (BMI)(kg/m^2) | Eluxadoline 75 mg | Eluxadoline 100 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 30.70 ± 7.421 | 31.22 ± 7.858 | 30.63 ± 7.253 | 30.85 ± 7.513 |
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Furiex Pharmaceuticals, Inc